India Receives Good Laboratory Practices Certificate

August 2, 2011

In March 2011, India achieved the status of full adherence to Good Laboratory Practices (GLP) certified by the Organization of Economic Cooperation and Development (OECD). The OECD is composed of the world’s most advanced countries such as the US, the UK, Canada, Australia, etc. This international recognition is a giant leap forward for India in the field of quality compliance.

Previously, manufacturers wanting to export pharmaceuticals had to conduct tests overseas. Now, the OECD certificate should help to ensure that the results of chemical safety-tests as well as clinical and non-clinical trials done in India will be accepted in all other 34 member countries. At present, there are 18 GLP-certified facilities in India: 6 of which are pharmaceutical and agrochemical companies, and 12 of which are contract research organizations and government laboratories.

In addition, India has proposed new regulations on clinical trials and Clinical Research Organizations (CROs) in India. Once in effect, some risky medical devices will require local clinical trials in India. These regulations will stress the quality of the clinical trials and the need for more skilled CRO staff. CROs and clinical trials will be more strictly regulated in India to reduce corruption and increase accuracy so they can be used for more global clinical trials and product registration.

India’s commitment to cleaner and more transparent clinical and non-clinical trials has made the country a prime location for foreign drug companies. Additionally, costs for trials in India can be up to 60% less than those in the US. For foreign pharmaceutical companies, there will be an increasing number of clinical trials done in India in the near future.